On 16-Sep-08, US FDA imposed a ban on 30 drugs made by Ranbaxy in India; and also stop approving any new drugs made at these 2 plants, located in  until the deficiencies in production process sited at Dewas in Madhya Pradesh and Paonta Sahib Uttar Pradesh facilites are resolved.

The import ban affects a number of key generic drugs like cholesterol-lowering simvastatin and pravastatin, several AIDS medications, antibiotic ciprofloxacin, OHGA metformin, allergy drug loratadine etc. The FDA also advised patients not to stop taking any medications and to talk to their healthcare professionals to address any concerns which they may have.

The move is the latest blow against India's leading generic drug maker, which is also the subject of a separate criminal probe by the U.S. Justice Department for allegedly bringing adulterated and misbranded medications into the United States. In a separate statement, Ranbaxy Laboratories said it has hired former New York City Mayor Rudolph Giuliani as an adviser to guide it in countering the import ban imposed by FDA. Giuliani is no stranger to advising drug companies. He has formerly provide advice to US-based Purdue Pharma, a drug maker, embroiled in a controversy over OxyContin, a painkiller, and helped keep its executives out of jail by negotiating a settlement with the US Federal Prosecutors.

The FDA’s decision to ban the importation of Ranbaxy’s drugs was based on FDA’s audit of the above 2 production sites. FDA officials have been trying to resolve the problems with the company, which still has not cleaned up its processes involving numerous instances of lax written records that are supposed to keep track of equipment cleaning, production controls, and product quality. FDA inspectors, who most recently searched the plants between January and March 2008, also cited problems with factory workers who did not keep some antibiotics properly contained. These have culminated in the FDA issuing two separate letters to Ranbaxy on 16-Sep-08.
 
The FDA said the import ban would be lifted when the company resolved the violations. Following FDA’s action, our Singapore HSA also issued a public advisory on 22-Sep-08 on this issue to address the concerns of local consumers and healthcare professionals. The full text of the HSA advisory can be read here: http://www.hsa.gov.sg/publish/etc/medialib/hsa?library/corporate/up20072009.Par.82890.File.tmp/HSAUpdates-USFDAActionsOnProductsManufacturedBy2RanbaxyManufacturingPlantsInIndia?22Sep08.pdf

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